New generic valsartan gets FDA approval

A new generic heart and blood pressure drug valsartan has been approved by the FDA to address recent shortages caused by the 2018 recalls of generic valsartan products from multiple manufacturers found to be contaminated with nitrosamine impurities. Approval was based on an evaluation of the company’s manufacturing processes to ensure appropriate testing methods were being employed to evidence that N-nitrosodiethylamine and N-nitrosodimethylamine were not present.
Scott Gottlieb, FDA commissioner, said: “We know that the ongoing recalls to prevent certain lots of valsartan that contain unacceptable limits of impurities from reaching patients has resulted in a shortage of these important medicines, so to address the public health consequences of these shortages, we’ve prioritised the review of generic applications for these valsartan products. We hope that today’s approval of this new generic will help reduce the valsartan shortage, and we remain committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes for existing and future products.”